DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 10/28/2025 has been entered. Claims 1, 7, and 14-16 have been amended. Claims 1-16 are still pending in the application.
Response to Arguments
Applicant's arguments filed 10/28/2025 have been fully considered but they are not persuasive.
As for the 35 USC 112(b) rejections, the rejections found in the Office action of 09/16/2024 have not been overcome by amendment. This rejection can be found below.
Regarding applicant’s attempts to define the structure of the invention using the instant disclosure “the present invention developed an external standard series using impregnated nanomaterials, for example, in the form of a barcode having several fields (thus a series), wherein the fields of the barcode are standardized from zero to one. Ligand bonds were completely dispensed with. The signal-transmitting nanomaterials are available in dry, impregnated form, can be used several hundred times and have a half-life of several months”, the Appellant is reminded that it is the language of the claims what defines the patentable subject matter, not the detailed description of the invention or the drawings. Reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is quite different from reading limitations of the specification into a claim, to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the language of the claim. In re Prater, 162 USPQ 541 (CCPA 1969). In this case, claim 1 recites generic method steps, using nanomaterial, measuring signals, standardizing via internal/external series. All the specific embodiments of internal/external standard series generation, SERS normalization, barcode layout, controls, and AI/dosage applications have no express basis in the claim.
In response to applicant’s arguments that Salehi et al. (EP 3 034 616 Al), Alderman et al. (US Pub 2015/0031047 A1), and Niedenzu et al. (WO 2013/189860 A2) disclose specifically “the external standard series must be prepared daily, sometimes several times a day, with the aid of biological ligands. They are created by dilution series of a substance or nanomaterials in liquids and must be disposed of after each measurement, as the ligand bonds have only a defined and usually short half-life”, and not simply “an external standard series using impregnated nanomaterials, for example, in the form of a barcode having several fields (thus a series), wherein the fields of the barcode are standardized from zero to one. Ligand bonds were completely dispensed with. The signal-transmitting nanomaterials are available in dry, impregnated form, can be used several hundred times and have a half-life of several months”, the applicant is respectfully advised it has been held by the courts that the use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. In re Heck, 216 USPQ 1038 and In re Lemelson, 158 USPQ 275. In this case, the amended claim 1 merely requires “measuring an internal standard series of the rapid test and/or external standard series of the rapid test”, it does not define whether the external series is wet or dry; whether it uses ligands or not; whether it requires daily preparation; whether it must be reusable; whether it must be integrated into the rapid test; whether it replaces dilution standards. Claim 6 is the only claim mentioning “external standard series” requires: “measuring surfaces with different concentrations; immobilized signal-active material; and optionally sealed.” There are no limitations on reusability, stability, ligand-free, 0-1 barcode, replacing dilution standards, and prohibiting daily preparation. Therefore, the claim reads on any internal/external standard series, including liquid dilution external standards, ligand-based external standards, daily-prepared external standards, and disposable external standards.
In response to applicant’s arguments that Salehi et al. (EP 3 034 616 Al), Alderman et al. (US Pub 2015/0031047 A1), and Niedenzu et al. (WO 2013/189860 A2) failed to disclose individually, or suggest in combination, “an internal Raman-based standard series without material preparation or an external standard series with impregnated, long-lasting nanomaterials without ligand binding; perform a quantitative evaluation or derive a standard curve based on the Raman or SERS signals; uses an internal Raman-based standard series and an external barcode structure as part of a rapid test, which enables mathematically defined and reproducible concentration determination in biological samples; the fluorescence quantification of the present invention is based on a bioligand free standard series as part of the rapid test; is based on the quantification of analytes in biological samples such as serum, urine or milk, using an internal Raman-based standard series and an external barcode structure that enables mathematically defined concentration determination; quantitative laboratory values that reflect the function of internal organs are used to calculate a therapeutically relevant dosage. The medical logic is based on real concentration values, not on administrative assignments; impregnated nanomaterials in a barcode form or the like, is ligand-free, reusable and has a half-life of several months. The internal standard series is based on a constant Raman signal that is generated without additional preparation”, the applicant is respectfully advised that while the claims of issued patents are interpreted in light of the specification, prosecution history, prior art and other claims, this is not the mode of claim interpretation to be applied during examination. During examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, 70 USPQ2d 1827 (Fed. Cir. May 13, 2004). In this case, the claims only recite the concept, measuring an internal and/or external standard series and using it for absolute quantification of an analyte in a rapid test. None of these novel structural or procedural details in the arguments are explicitly claimed. There are no mention of external standard series using impregnated, ligand-free nanomaterials (barcode structure); ligand-free, reuse, long half-life, or biological sample types. Therefore, the claims remain conceptually broad.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification is devoid of any algorithm, flow chart, steps, or big data approach for showing how each section is configured to perform its associated function.
More specifically, applicant claims an algorithm or big data approach to adjust or personalize the medication dose or to make dosing recommendations for medications or active ingredients for future patients.
The specification does not provide any algorithm to for how to make a dosing recommendation, as such we do not know what applicant is in possession of. How does applicant adjust or personalize the medication dose , or to make dosing recommendations for medications or active ingredients for future patients. There is no disclosed steps that would show one of ordinary skill in the art that the applicant as required by claim 16.
MPEP 2161 recites "It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement." In the instant case, the specification suggests a genera! Purpose computer, however omits the actual algorithm in order to achieve the claimed functions. Therefore the claim fails to meet the written description requirement.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 is an apparatus with luminescent substance, includes a method step of using a data processor to standardize the concentration of the analyte. It is unclear if the apparatus is infringed with the only structural limitation of the nanomaterial, or when a processor used to standardize the concentration. The examiner suggests changing the claim to a data processor configured to.
Claim 15 recites “using the method according to claim 1 in human medicine, in veterinary medicine and/or in the food industry, to carry out a quantitative determination of active substances, medicaments and/or toxins by a rapid test.” The recited limitation is a method claim that does not recite any active method steps. See MPEP 2173.05(q) for more information.
Claim 16 recites the limitation “by means of AI algorithms and/or by big data approaches” , (line 6) is vague and indefinite because the claim does not provide a sufficient structural description or algorithmic detail for performing the recited function of “adjust or personalize the medication dose and/or to make dosing recommendations.” The recited function does not follow from the structure recited in the claim i.e. “AI algorithms and/or big data approaches” do not identify any specific algorithm, model architecture, training procedure, or logic flow necessary to perform the claimed function. Thus, one of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claim. For the purposes of examination, “AI algorithms and/or big data approaches” will be interpreted to be any computational or data processing techniques that relate to AI or big data.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4-5, 7-10, and 13- 15 are rejected under 35 U.S.C. 103 as being unpatentable over Salehi et al. (EP 3034616 A1, disclosed in IDS 02/12/2024 )(hereinafter, “Salehi ”) in view of O’Farrell et al. (US Pub 2014/0024016 A1)(hereinafter, “O’Farrell”).
Regarding claim 1, Salehi teaches a method for the absolute quantification (teaches a method that uses surface-enhanced Raman scattering (SERS) combined with nanomaterials for the quantification of proteins, [0069-0070]) of at least one analyte (protein analytes such as BSA and IgG, [0063] and [0069], teaches quantitative measurement of protein/nanoparticles, [0059] and [0069]) by a (teaches vacuum filtration ,[0075], combined with immediate spectroscopy, [0069-0074]) ,including, spectroscopic determination(uses UV/VIS and Raman spectrometers for protein quantification via SERS, [0047] and [0069-0070]), comprising the steps of:
Using at least one nanomaterial in the as a luminescent substance for quantification(teaches gold nanoparticles, used as SERS-active probes, [0047]), wherein the at least one nanomaterial interacts directly or indirectly with the analyte([0063] teaches IgG is covalently coupled to surface of SERS nanoparticles),
Measuring at least one signal generated by the nanomaterial of the (measured via SERS spectra(at about
1340
c
m
-
1
), [0070]).
Salehi fails to disclose a rapid test, measuring an internal standard series of the rapid test and/or external standard series of the rapid test, and subsequently
standardizing or referencing the generated signal using said measured internal and/or external standard series, so that an absolute quantification of the analyte is achieved.
O’Farrell teaches a rapid test (discloses lateral flow tests and rapid assay device, [0116]), measuring an internal standard series of the rapid test ([0126-0129]) and/or external standard series of the rapid test, and subsequently
standardizing or referencing the generated signal using said measured internal (discloses internal, measured calibration features that are used to reference analyte signals, “analysis of the signal strengths generated at these features”, “generation of a variety of internal calibration features within the flow field”, [0118-0119] and [0126-0129]) and/or external standard series, so that an absolute quantification of the analyte is achieved ([0127] and [0129]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate on-strip calibration and combined signal analysis of O’Farrell to Salehi to allow standardized ([0127] and [0129]), quantitative analyte measurement ([0122]), and improve accuracy ([0118]).
Regarding claim 2, Salehi teaches wherein a background material, a component, a plastic part, a plastic housing and/or a nitrocellulose membrane (teaches plastic is used as a background material that gives off a constant Raman signal, [0070]) is used as the target to be measured for measuring an internal standard series(the plastic background signal is measured and used as an internal standard series, [0071]), by which a constant measurement signal can be measured for defined measurement parameters independently of the concentration of the analyte(teaches the plastic signal is constant regardless of protein concentration, [0071]) and thus this background measurement signal can be used for standardization of the generated signal of the nanomaterial (discloses the use of a plastic background Raman signal for standardization of nanomaterial based SERS signals, [0071] and [0073]).
Salehi fails to disclose a rapid test.
O’Farrell teaches a rapid test (discloses lateral flow tests and rapid assay device, [0116]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate on-strip calibration and combined signal analysis of O’Farrell to Salehi to allow standardized ([0127] and [0129]), quantitative analyte measurement ([0122]), and improve accuracy ([0118]).
Regarding claim 4, Salehi teaches wherein the measurement of the internal and/or the external standard series is carried out using Raman-labelled targets (gold nanoparticles that have been functionalized with a Raman reporter molecule, 4- mercaptobenzoic acid (4-MBA), [0046]. The Raman labeled nanoparticles are used for SERS based detection and quantification, [0069-0070]) and/or fluorescence-labelled targets.
Regarding claim 5, Salehi teaches wherein, in order to measure an internal standard series(the plastic background signal is measured and used as an internal standard series, [0071]), the at least one target is measured with different intensities of an irradiated light (teaches measuring a plastic background under different laser conditions (exposure time), [0071]), with different laser powers (uses of variable laser conditions (exposure time), by changing the exposure time, it inherently adjusts laser power, [0071]) and/or with a changed laser focus, so that a plurality of measurements of a standard series are obtained (teaches uses the plastic background Raman signal as an internal standard to automatically correct /normalize the SERS signal of the analyte, [0071])
Regarding claim 7, Salehi teaches wherein at least one nanomaterial as luminescent substance (teaches gold nanoparticles, used as SERS-active probes, [0047]) is an IgG-coupled Raman-active nanomaterial (gold nanoparticles that have been functionalized with a Raman reporter molecule, 4- mercaptobenzoic acid (4-MBA), [0046]), and/or the measurement of the signal generated by the nanomaterial is carried out by surface-enhanced Raman scattering, so that the generated signal is a surface-enhanced Raman scattering signal (uses gold nanoparticles functionalized with 4-MBA as SERS-active probes, and the signal generated by these nanoparticles is a SERS signal, which is used for protein quantification, [0046] and [0069-0070]).
Regarding claim 8, Salehi teaches wherein the rapid test is a lateral flow assay or a vertical flow assay or Western blot and/or quantum dots upconversion and/or nanomaterials are used for the quantification of the analyte(uses gold nanoparticles functionalized with 4-MBA as SERS-active probes, and the signal generated by these nanoparticles is a SERS signal, which is used for analyte quantification, [0046] and [0069-0070]), the nanomaterials being coated with a self-assembling single layer or a monolayer of organic molecules as Raman markers (uses gold nanoparticles functionalized with 4-MBA, which serves as the Raman marker for SERS signal detection, [0046] and [0069-0070]) and/or such materials or nanomaterials being coupled to ligands, such as protein A, protein G, protein A/G, protein L, biotinylated antibodies or enzyme-coupled and fluorescent antibodies, for the quantification of the analyte.
Regarding claim 9, Salehi teaches wherein the at least one nanomaterial is a nanocrystalline luminescent substance which comprises LaPO4:Ce3+, LaPO4:Pr3+, LuPO4:Pr3+, LaPO4:Tm3+ LuPO4:Dy3+, LuPO4:EU3+, LuPO4:Tb3+, LuPO4:Tm3+ and is formed therefrom and/or that the at least one nanomaterial is a nanomaterial (gold nanoparticles that have been functionalized with a Raman reporter molecule, 4- mercaptobenzoic acid (4-MBA), [0046-0047]) or microparticles produced by doping, from a plastic polymer.
Regarding claim 10, Salehi teaches wherein the measurement is carried out by a UV, UV-VIS, IR, fluorescence and/or Raman spectrometer (uses UV/VIS and Raman spectrometers for protein quantification via SERS, [0047] and [0069-0070]).
Regarding claim 13, Salehi teaches characterized by a simultaneous (discloses both plastic Raman band (internal standard) and proteins SERS signal (analyte) are captured simultaneously in the same Raman spectrum, [0070-0072]) or immediately successive exposure of the standard series and the at least one nanomaterial (gold nanoparticles that have been functionalized with a Raman reporter molecule, 4- mercaptobenzoic acid (4-MBA), [0046-0047]) by spectroscopy in a spectrum range from UV to IR (uses both UV/VIS and SERS, which fall within the UV to IR spectrum range, [0047] and [0069-0070]).
Regarding claim 14, Salehi teaches device for the absolute quantification(teaches a filtration/dialysis device for separating and quantifying protein analytes using SERS and internal standard normalization, [0069-0071]) of at least one analyte(protein analytes such as BSA and IgG, [0063] and [0069]) combined with immediate spectroscopy, [0069-0074]) that uses surface-enhanced Raman scattering ([0069-0071]), with
at least one nanomaterial as a luminescent substance for quantification, which interacts directly or indirectly with the analyte(uses gold nanoparticles functionalized with 4-MBA as SERS-active probes, and the signal generated by these nanoparticles is a SERS signal, which is used for protein quantification, [0046] and [0069-0070]), measured by a spectrometer (uses UV/VIS and Raman spectrometers for protein quantification via SERS, [0047] and [0069-0070]) or by at least one filter and at least one sensor in order to measure at least one signal generated by the nanomaterial and an internal and/or external standard series, by Raman-labeled targets and/or fluorescence-labeled targets, wherein
using a data processing device (discloses processing measurement signals (UV/VIS and SERS), [0047] and [0069-0070], that inherently require instrumentation with data processing), the concentration of the analyte is standardized or referenced using the internal and/or external standard series (plastic substrate Raman signal, then subsequently uses it to correct/normalize the SERS signals, [0070-0071]), so that an absolute quantification of the analyte is achieved (teaches quantitative analyte calculation using internal Raman bands instead of an external standard series, achieving absolute quantification without traditional calibration curves, as a replacement for ELISA and quantifies proteins without standard curve, [0072-0074]).
Salehi fails to disclose a rapid test.
O’Farrell teaches a rapid test (discloses lateral flow tests and rapid assay device, [0116]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate on-strip calibration and combined signal analysis of O’Farrell to Salehi to allow standardized ([0127] and [0129]), quantitative analyte measurement ([0122]), and improve accuracy ([0118]).
Regarding claim 15, Salehi teaches in human medicine(teaches use of IgG antibodies in immunotherapy, a filtration/purification method to remove antibody aggregates to ensure safe clinical use of these antibodies, [0078-0079]), in veterinary medicine and/or in the food industry, in particular to carry out a quantitative determination of active substances((uses UV/VIS and Raman spectrometers for protein quantification via SERS, [0047] and [0069-0070]), medicaments (therapeutic IgG antibodies purified and quantified for therapy, [0078-0079]).
Salehi fails to disclose a rapid test.
O’Farrell teaches a rapid test (discloses lateral flow tests and rapid assay device, [0116]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate on-strip calibration and combined signal analysis of O’Farrell to Salehi to allow standardized ([0127] and [0129]), quantitative analyte measurement ([0122]), and improve accuracy ([0118]).
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Salehi et al. (EP 3034616 A1)(hereinafter, “Salehi ”) in view of O’Farrell et al. (US Pub 2014/0024016 A1)(hereinafter, “O’Farrell”), further in view of Alderman et al. (US Pub 2015/0031047 A1)(hereinafter, “Alderman”).
Regarding claim 3, Salehi teaches wherein a control line is measured to measure an internal standard series (teaches constant Raman signal from plastic background (e.g., at 1000
c
m
-
1
), [0070]) and the measured value obtained is used as a reference value (teaches the Raman signal of nanomaterial is corrected by constant plastic signal, [0071])for standardization of the generated signal of the nanomaterial(plastic substrate Raman signal, then subsequently uses it to correct/normalize the SERS signals, [0070-0071]).
Salehi fails to disclose a rapid test; with a supplementary calculation of the analyte using a 4-parameter logistic .
O’Farrell teaches a rapid test (discloses lateral flow tests and rapid assay device, [0116]).
Alderman in the field of biochemical assays and molecular diagnostics teaches a supplementary calculation of the analyte using a 4-parameter logistic (teaches the assay output (AMMP signal) is plotted vs. log(dilution) and fit to a 4-parameter logistic equation to determine analyte concentration, [0155-0157].
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate a 4-parameter logistic (4PL) model of Alderman to Salehi in view of O’Farrell to enhance the accuracy of analyte quantification ([0153]).
Regarding claim 6, Salehi in view of O’Farrell teaches all limitations of claim 1 but fails to teach wherein for a measurement of an external standard series a plurality of measuring surfaces are provided, each with a different concentration of a separately prepared signal-active material and/or at least one nanomaterial, the signal-active material and/or the nanomaterial being particularly preferably immobilized on an attachment or on the rapid test and optionally sealed.
Alderman in the field of biochemical assays and molecular diagnostics teaches wherein for a measurement of an external standard series(the set of prepared, calibrated bead-based assay standards (e.g., beads with immobilized preprooxytocin or known recombinant oxytocin) at known concentrations used to generate a standard curve, [0207], and [0219-0222] ) a plurality of measuring surfaces are provided (teaches multiple beads with different immobilized materials as measuring surface in the system, [0220] and [0235]), each with a different concentration of a separately prepared signal-active material and/or at least one nanomaterial (teaches different beads carry different amounts of immobilized protein and fluorescent antibody, ([0218-0220]), the signal-active material (proteins, antibodies, [0216-0217]) and/or the nanomaterial being particularly preferably immobilized on an attachment (teaches bead-immobilized oxytocin prepropeptide, [0218]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate an external standard series a plurality of measuring surfaces of Alderman to Salehi in view of O’Farrell to enhance the generation of calibrated standard curves, thereby improving the accuracy and reliability of absolute quantification of the analyte ([0207] and [0221]).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Salehi et al. (EP 3034616 A1)(hereinafter, “Salehi ”) in view of O’Farrell et al. (US Pub 2014/0024016 A1)(hereinafter, “O’Farrell”), further in view of Lambert et al. (US Pub 2010/0055721 A1)(hereinafter, “Lambert”).
Regarding claim 11, Salehi in view of O’Farrell teaches all limitations of claim 1 but fails to teach wherein a measurement and in particular a spectroscopic examination of a positive and a negative control is carried out in parallel with the measurement of the signal of the nanocrystalline luminescent substance generated by the nanomaterial.
Lambert in the field of biochemical sensing and analytical diagnostics teaches wherein a measurement(teaches Raman spectral measurements to detect analytes in biosensors and lateral flow assays, [0145] and [0151]) and in particular a spectroscopic examination(teaches spectroscopic techniques such as fluorescence lifetime measurements and SERS, [0145] and [0150-0153]) of a positive and a negative control is carried out in parallel (teaches the distinct strips each containing specific SERS nanoparticle-antibody conjugates as positive controls by detection of their target analytes, the absence or reduction of signal in other strips, such as those with diluted mixtures or non-target conjugates, as negative/baseline controls. Since all these strips are run simultaneously on the same lateral flow membrane, the system inherently performs parallel measurements of positive and negative conditions within the same assay run, [0154-0156]) with the measurement of the signal of the nanocrystalline luminescent substance generated by the nanomaterial (teaches SERS tags comprise a metal (gold/silver) nanoparticle coated with a highly adsorbing SERS active chemical 710, [0153]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate parallel spectroscopic examination of positive and negative controls of Lambert to Salehi in view of O’Farrell to enhance accurate quantification via Raman spectral analysis, thereby improving both the accuracy and robustness of the assay ([0156]).
Regarding claim 12, Salehi in view of O’Farrell teaches all limitations of claim 1 but fails to teach wherein at least one nanocrystalline luminescent substance is used for measuring the standard series and/or at least one fluorescent dye is used as luminescent substance for quantifying the analyte.
Lambert in the field of biochemical sensing and analytical diagnostics teaches wherein at least one nanocrystalline luminescent substance(teaches SERS tags comprise a metal (gold/silver) nanoparticle coated with a highly adsorbing SERS active chemical 710, [0153]) is used for measuring the standard series (teaches the array of strips each with known SERS nanoparticle conjugates (single analytes and mixtures) at defined concentrations, used for calibration and quantification, [0154-0155]) and/or at least one fluorescent dye is used as luminescent substance for quantifying the analyte.
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate the use of nanocrystalline luminescent substances in the measurement of the standard series of Lambert to Salehi in view of O’Farrell to enhance sensitivity, multiplexing capability, and signal clarity, thereby improving the accuracy and reliability of analyte quantification ([0150-0158]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Salehi et al. (EP 3034616 A1)(hereinafter, “Salehi ”) in view of O’Farrell et al. (US Pub 2014/0024016 A1)(hereinafter, “O’Farrell”), further in view of Niedenzu et al. (WO 2013/189860 A2)(hereinafter, “Niedenzu”).
Regarding claim 16, Salehi in view of O’Farrell teaches absolutely quantified measured values (teaches a method that uses surface-enhanced Raman scattering (SERS) combined with nanomaterials to generate quantitative data on protein analytes, [0069-0070]).
Salehi in view of O’Farrell fails to teach using said measured values and said further data and/or said information for AI algorithms and/or in big data approaches to adjust or personalize the medication dose or to make dosing recommendations for medications or active ingredients for future patients.
Niedenzu in the field of medical diagnostics and drug administration verification technology teaches using said measured values and said further data and/or said information for AI algorithms and/or in big data approaches (spectroscopically acquired data, [page 45, lines 28-31], [page 46, lines 3-20], [page 47, lines 33-36] , [page 48, lines 11- 15 and 42-45]) to adjust or personalize the medication dose (detects exact concentrations (e.g., 1.49% vs. 1.51% KCI), flags unexpected concentrations, which helps inform correct dosing, page 46, lines 43-46) or to make dosing recommendations for medications or active ingredients for future patients.
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate a method to adjust the medication dose of Niedenzu to Salehi in view of O’Farrell’s absolutely quantified measured values to enables the detection of incorrect dosing, provides real-time feedback to users, and supports corrective actions to optimize therapeutic outcomes ([page 45, line 24] and [ page 47, lines 22-36]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA XING whose telephone number is (571)270-7743. The examiner can normally be reached Monday - Friday 9AM - 5 PM.
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/CHRISTINA I XING/Examiner, Art Unit 2877
/Kara E. Geisel/Supervisory Patent Examiner, Art Unit 2877